Central Nervous System InfectionNCT01438879
Lymphocytic Herpesviruses and Cerebrospinal Fluid Polymerase Chain Reaction (PCR)
An observational study of Central Nervous System Infection, run by PaijatHame Central Hospital at 1 site in Finland.
Trial summary
Enterovirus and herpes simplex viruses 1 and 2 are the main causative agents of central nervous system infections. Instead, the role of lymphocytic herpesviruses in the etiology of central nervous system (CNS) infections is not clear, even if there is the positive cerebrospinal fluid (CSF) polymerase chain reaction… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Central Nervous System Infection
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents of the district of Paijat-Hame (200 000 inhabitants).
Who may be able to join
- Immunocompetent patients with clinical symptoms and signs of central nervous system infections and CSF pleocytosis (pleocytosis group)
- Immunocompetent patients without suspicion of CNS infection and no CSF pleocytosis (non-pleocytosis group)
Who cannot join
- Suspicion of CNS-infection, eg. encephalitis, but no CSF leukocytosis (pleocytosis group)
- Patients without symptoms of CNS infection, but who has CSF pleocytosis of unknown origin (non-pleocytosis group)
Trial locations and contacts
1 site in 1 country.
Finland1 site
PaijatHame Central Hospital
Lahti, 15850
Laura Kupila, laura.kupila@phsotey.fi
Laura Kupila
About this study
Official title: Molecular Methods in the Etiological Diagnostics of Acute Central Nervous System Infections: Lymphocytic Herpesviruses and PCR
Enterovirus and herpes simplex viruses 1 and 2 are the main causative agents of central nervous system infections.
Instead, the role of lymphocytic herpesviruses in the etiology of central nervous system (CNS) infections is not clear, even if there is the positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR)-result for the virus.
The aim of this study is to evaluate the presence of DNA from lymphocytic herpesviruses in the CSF obtained from the immunocompetent patients with CSF pleocytosis and from the patients with normal CSF leukocyte count.
- Conditions
- Central Nervous System Infection
- Keywords
- CSF, PCR, lymphocytic herpesvirus, CNS
- Medical subject headings
- Central Nervous System Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pleocytosis group | 40 patients with clinical signs of CNS infection and having CSF pleocytosis. | |
| non-pleocytosis group | 20 patients not having CNS infection clinically and not having CSF pleocytosis. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PaijatHame Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Laura Kupila, PaijatHame Central Hospital
- Investigators
- Laura MA Kupila, Principal investigator, PaijatHame Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438879
- Sponsor's protocol ID
- R11077
- Status last verified
- Sep 2011
- First submitted
- 20 Sep 2011
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Methods in the Etiological Diagnostics of Acute Central Nervous System Infections: Lymphocytic Herpesviruses and PCR
- ClinicalTrials.gov ID
- NCT01438879
- Acronym / sponsor ID
- R11077
- Conditions
- Central Nervous System Infection
- Keywords
- CSF, PCR, lymphocytic herpesvirus, CNS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PaijatHame Central HospitalUniversity, hospital or other
- Collaborators
- University of Turku
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enterovirus and herpes simplex viruses 1 and 2 are the main causative agents of central nervous system infections.
Instead, the role of lymphocytic herpesviruses in the etiology of central nervous system (CNS) infections is not clear, even if there is the positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR)-result for the virus.
The aim of this study is to evaluate the presence of DNA from lymphocytic herpesviruses in the CSF obtained from the immunocompetent patients with CSF pleocytosis and from the patients with normal CSF leukocyte count.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pleocytosis group | – | –40 patients with clinical signs of CNS infection and having CSF pleocytosis. |
| non-pleocytosis group | – | –20 patients not having CNS infection clinically and not having CSF pleocytosis. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of the district of Paijat-Hame (200 000 inhabitants).
Key inclusion criteria (2 listed)
- Immunocompetent patients with clinical symptoms and signs of central nervous system infections and CSF pleocytosis (pleocytosis group)
- Immunocompetent patients without suspicion of CNS infection and no CSF pleocytosis (non-pleocytosis group)
Key exclusion criteria (2 listed)
- Suspicion of CNS-infection, eg. encephalitis, but no CSF leukocytosis (pleocytosis group)
- Patients without symptoms of CNS infection, but who has CSF pleocytosis of unknown origin (non-pleocytosis group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura MA Kupila principal investigator
PaijatHame Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Infection, run by PaijatHame Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura MA Kupila (+358447195940, laura.kupila@phsotey.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2011.